CoreLink® M3™ Stand-Alone Anterior Lumbar System

Intervertebral Fusion Device With Integrated Fixation, Lumbar

CoreLink, LLC

The following data is part of a premarket notification filed by Corelink, Llc with the FDA for Corelink® M3™ Stand-alone Anterior Lumbar System.

Pre-market Notification Details

• Device ID: K180814
• 510k Number: K180814
• Device Name: CoreLink® M3™ Stand-Alone Anterior Lumbar System
• Classification: Intervertebral Fusion Device With Integrated Fixation, Lumbar
• Applicant: CoreLink, LLC 7911 Forsyth Blvd., Suite 200 St. Louis, MO 63105
• Contact: Steve Mounts
• Correspondent: Meredith L May; Empirical Consulting, LLC 4628 Northpark Dr Colorado Springs, CO 80918
• Product Code: OVD
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-03-29
• Decision Date: 2018-08-10
• Summary: summary